As testosterone use grows, questions on risks await answers

PHILADELPHIA -- A dozen years ago, a major federal study shattered the deeply held belief that menopausal hormone therapy was the key to keeping women of a certain age healthy, sexy and in good moods.

By showing the therapy did more harm than good, the study shriveled up lucrative hormone sales and set off a wave of lawsuits.

Flash forward. It looks, as Yogi Berra said, like deja vu all over again -- this time for men.

Even as female hormone replacement was collapsing, male hormone replacement was catching on.

This wasn't because of convincing evidence that boosting testosterone helps men fight the toll of aging. It was mostly driven by the introduction of convenient, rub-on testosterone products starting in 2000 and the selling of those products as an answer to low energy, low libido, low mood -- what marketers call "Low T."

Now that the quintessential male steroid is a $2 billion market -- with nearly 3 percent of men over 40 estimated to be taking it in 2011 -- there are signs of trouble.

Two recent studies suggest testosterone supplementation raises the risk of heart attack, stroke and death. The Food and Drug Administration has begun an investigation, and law firms have begun filing product-liability suits.

In another echo of the female hormone saga, the federal government has stepped in to do the kind of costly, rigorous, placebo-controlled clinical trial that drug companies have no incentive to do. The $50 million Testosterone Trial is now wrapping up and will present results next year, said the leader, University of Pennsylvania endocrinologist Peter J. Snyder.

But size and duration do matter in research.

The Women's Health Initiative -- with 16,600 women taking estrogen-progestin pills for five years -- had what scientists call "statistical power." That's why, despite criticism, the results have held sway.

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As testosterone use grows, questions on risks await answers